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`
`g éDEPARTMENTOFHEALTHANDHUMANSERVICES
`
`“Q
`
`Food and Drug Administration
`Silver Spring MD 20993
`
`SUPPLENIENT APPROVAL
`
`NBA 208 144/S-001
`
`Bausch + Lomb
`
`Attention: Shaun A. Mbithi
`
`Senior Manager, Regulatory Affairs
`400 Somerset Corporate Boulevard
`Bridgewater, NJ 08807
`
`Dear Ms. Mbithi:
`
`Please refer to your supplemental New Drug Application (sNDA) dated and received May 18,
`2018, and your amendments, submitted pursuant to section 505(b)(2) of the Federal Food, Drug,
`and Cosmetic Act (FDCA) for Lumify (brimonidine tartrate ophthalmic solution, 0.025%).
`
`We acknowledge receipt of your amendment dated and received November 2, 2018, which
`constituted a resubmission following our Refusal to File letter dated July 17, 2018.
`
`This “Prior Approval” supplemental new drug application provides for the addition of a 0.4 mL
`fill size
`mm in an aluminum pouch; the
`addition of a drug product manufacturing, packaging, release testing and stability testing site at
`«our and the addition of contract laboratories M“)
`’
`mm»
`
`to perform
`
`analytical testing.
`
`We have completed our review of this application, as amended. It is approved, effective on the
`date of this letter, for use as recommended in the agreed—upon labeling text.
`
`LABELING
`
`Submit final printed labeling (FPL), as soon as they are available, but no more than 30 days after
`they are printed. The FPL must be identical to the submitted labeling and must be in the “Drug
`Facts” format (21 CFR 201.66), where applicable.
`
`Reference ID: 4394303
`
`

`

`Submitted Draft Labeling
`
` 0.4 mL (single dose) foil pouch (sample) – updated to
`
`
` remove the gray color from the seal area
`
`
` 0.4 mL (single dose) carton (sample)
`
`
`
` 0.4 mL (single dose) vial (sample and trade)
`
`
` Coupon (Save $2.00 on 7.5 mL size)
`
`
` 0.4 mL (single dose) foil pouch (trade)
`
` 0.4 mL (single dose) carton (trade)
`
`
`
` The FPL should be submitted electronically according to the guidance for industry titled
`
`
`
`
` Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical
`Product Applications and Related Submissions Using the eCTD Specifications (April 2017,
`Revision 4). For administrative purposes, designate this submission “Final Printed Labeling
`
`
`
`
`for approved NDA 208144/S-001.” Approval of this submission by FDA is not required before
`
`
`
`the labeling is used.
`
`
`Remove the “New Product” text from the principal display panel 6 months after introduction into
`
`
`
`
`the marketplace.
`
`
`DRUG REGISTRATION AND LISTING
`
`
`
`All drug establishment registration and drug listing information is to be submitted to FDA
`
`
`
`electronically, via the FDA automated system for processing structured product labeling (SPL)
`
`
`
`files (eLIST). At the time that you submit your final printed labeling (FPL), the content of
`
`
`
`labeling (Drug Facts) should be submitted in SPL format as described at
`
`
`
`
`
`
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm.
`Information on submitting SPL files using eLIST may be found in the guidance for industry
`
`
`
`
`
`titled “SPL Standard for Content of Labeling Technical Qs and As” at
`
`
`
`
`
`
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`
` CM072392.pdf. In addition, representative container or carton labeling, whichever includes
`
`
`
` Drug Facts, (where differences exist only in the quantity of contents statement) should be
` submitted as a JPG file.
`
`
`REQUIRED PEDIATRIC ASSESSMENTS
`
`
`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
`
`
`active ingredients (which includes new salts and new fixed combinations), new indications, new
`
`
`dosage forms, new dosing regimens, or new routes of administration are required to contain an
`
` assessment of the safety and effectiveness of the product for the claimed indication in pediatric
` patients unless this requirement is waived, deferred, or inapplicable.
`
`
` Because none of these criteria apply to your application, you are exempt from this requirement.
`
`
`
`
` Date Submitted
`
` November 2, 2018
`
`
`
` May 18, 2018
`
` May 18, 2018
`
` May 18, 2018
`
` January 22, 2019
`
` January 22, 2019
`
`
`
`
`
` NDA 208144/S-001
`
` Page 2
`
`
`
`
`
`
`
`Reference ID: 4394303
`
`

`

`
`
`
`
` NDA 208144/S-001
`
` Page 3
`
`
` REPORTING REQUIREMENTS
`
`
`
`
`We remind you that you must comply with reporting requirements for an approved NDA
`
`
`(21 CFR 314.80 and 314.81).
`
`
`
`
`
`If you have any questions, call Jung Lee, Regulatory Project Manager, at (301) 796-3599.
`
`
`
`Sincerely,
`
`
`{See appended electronic signature page}
`
`
`Karen Murry Mahoney, MD, FACE
`
`Deputy Director
`
`Division of Nonprescription Drug Products
`
`
`Office of Drug Evaluation IV
`
`Center for Drug Evaluation and Research
`
`
`
`ENCLOSURE(S):
`
`
`Carton and Container Labeling
`
`
`
`Reference ID: 4394303
`
`

`

`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`KAREN M MAHONEY
`02/21/2019 12:00:00 AM
`
`Reference ID: 4394303
`
`(
`
`
`
`